Clinical Research Directory

A Multi-Centre Study in Patients Undergoing Total Hip Arthroplasty With the Smith+Nephew CATALYSTEM™ Primary Hip System

A Multi-Center Study in Patients Undergoing Total Hip Arthroplasty with the Smith+Nephew CATALYSTEM™ Primary Hip System. The purpose of the study is to assess safety and performance of the CATALYSTEM™ and to support product approval in global markets.

Post Market Clinical Follow Up of LEGION™ Primary TKS With VERILAST™

LEGION™ Primary Total Knee System is CE-marked and marketed in all study regions. This study serves as post-market surveillance for LEGION™ Primary Total Knee System with the VERILAST™ bearing surface (OXINIUM™ femoral component with highly cross-linked polyethylene tibial insert). All study subjects will receive a LEGION™ Primary Total Knee System with VERILAST™ bearing surface and the results will be analysed against historical data from patients who received a Genesis II knee replacement.

Safety and Effectiveness of the HIT Reverse HRS

The purpose of this study is to determine if the use of the HIT Reverse Hip Replacement System is safe and effective in patients undergoing total hip replacement. We will determine whether it is safe and effective by comparing it to the control devices.

Zimmer Biomet Shoulder Arthroplasty PMCF Study

This is a multicenter, prospective, non-controlled post market surveillance study. The objectives of this study are to confirm the safety, performance, and clinical benefits of the Zimmer Biomet Shoulder Arthroplasty systems in primary anatomic shoulder arthroplasty and its instrumentation. Safety of the systems will be assessed by monitoring the frequency and incidence of adverse events. The performance and clinical benefits will be evaluated by assessment of the overall pain and functional performance, qualify of life, and radiographic parameters of all enrolled study subjects.

MRI of the TMJ in Patients With DJD

This observational research is comparative in design, that is assessing the change in qMRI measures in degenerative changes of the TMJ in patients diagnosed with DJD. These patients will be imaged multiple times over the course of 18 months, using clinical 3T MRI scanners located at the Center for Magnetic Resonance Research (CMRR), and their findings will be compared to controls; individuals who are not diagnosed with DJD. No investigational agents or MRI contrast agents will be used.

Hyaluronic Acid and Adelmidrol (Hyadrol®) in Patients With Degenerative Joint Disease

Osteoarthritis is a major cause of chronic musculoskeletal pain. Behind this disorder there is a process of chronic neuroinflammation due to the overactivation of mast cells at the tissue level. The mast cells present in the synovial membranes act as first sensors in pathological situations, degranulating in an uncontrolled manner. Furthermore, in degenerative joint pathologies, there is a marked reduction in the viscoelastic capacity of the synovial fluid associated with a reduction in both the concentration and the average molecular weight of endogenous hyaluronic acid. The association of hyaluronic acid and Adelmidrol (Hyadrol®) could represent an effective treatment for controlling the neuroinflammation process that supports degenerative joint diseases. The objective of the present clinical investigation is to evaluate its safety and efficacy in patients with arthritis of the hip (coxarthrosis) and trapezium-metacarpal joints (rhizoarthrosis).

Journey II BCS EU Observational Trial

Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.

Prospective Post-market Study Examining the Effectiveness of the EcoFit®

The purpose of this study is to evaluate the safety and effectiveness of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery.